On January 25, 2022 Curium reported a technology license agreement granting access to ECZACIBAŞI MONROL NÜKLEER ÜRÜNLER SANAYİ VE TİCARET A.Ş non carrier added Lutetium 177 (Press release, Curium, JAN 25, 2022, View Source [SID1234606799]). Curium also announced it will be funding the associated capital investment to build a production facility of 15000 Ci per annum on its Petten site in the Netherlands.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Curium’s Petten assets are co-located with the world’s largest research reactor and the site is already a world leader in the production of reactor based isotopes, the addition of Lutetium 177 will build on this leadership.

Earlier in the year Curium announced the initiation of its ECLIPSE phase three registration trial for its proprietary LuPSMA in the treatment of patients with metastatic castration resistant prostate cancer.

John Sylvester CEO of Curium’s SPECT and International businesses commented "this is a major milestone in the Curium’s transformation to an oncology therapy company. It builds on our philosophy of reliability of supply being the secret to success in Nuclear Medicine. In addition to serving our internal needs we have the proven global supply chain and sufficient capacity to serve the rapidly growing market for Lu-177 for therapeutic use".

He went on say "We are delighted with Monrol as a technology partner. After extensive benchmarking this technology gave both the highest quality product with the most efficient process. As it is already proven and ‘plug and play’ in nature, the time to market will be very short".

"Curium’s global reach and scale make them ideal partners for our world leading technology, and we are very pleased to announce them as partners" commented Mr. Aydin Kucuk General Manager of Monrol. Please direct all enquires in the first instance to: [email protected]

On January 25, 2022 Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, reported that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma (Press release, Cartesian Therapeutics, JAN 25, 2022, View Source [SID1234606767]). To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years. Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory cell manufacturing platform. This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Descartes-25 is designed to deliver two complementary antitumor proteins directly to the tumor: a novel three-arm bispecific antibody that binds B-cell Maturation Antigen (BCMA) with femtomolar avidity and the potent antitumor cytokine interleukin-12 (IL-12). Descartes-25 cells are further engineered with a membrane-bound homing protein that directs the cells to the tumor microenvironment for local delivery of their antitumor cargo. In preclinical models, Descartes-25’s IL-12 synergistically potentiates its BCMA bispecific antibody to eliminate myeloma with unprecedented activity.

"Patients with relapsed and/or refractory multiple myeloma have few treatment options remaining," said Kenneth Anderson, M.D., Kraft Family Professor of Medicine at Harvard Medical School and Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics. "A cell therapy that locally delivers a combination of a BCMA-bispecific antibody and IL-12, without using lymphodepleting chemotherapy, is an elegant and highly innovative approach. If approved, it will be a welcome addition to our toolkit for treating this currently incurable disease."

"We designed Descartes-25 to be highly potent and well tolerated by focusing on creating the ideal pharmacokinetic profile: continuous, measured, and local delivery of a synergistic combination of antitumor agents," said Murat Kalayoglu, M.D., Ph.D., President and Chief Executive Officer at Cartesian. "I am proud of our integrated team of scientists and physicians for their hard work and rapid clinical translation of this first-in-class therapy."

"With Descartes-25, Cartesian scientists used RNA Armory technology to convert stem cells into a targeted combination therapy," said Chief Scientific Officer Michael Singer, M.D., Ph.D. "Therefore Descartes-25 is not just a potent antitumor therapy. It’s also a blueprint for future RNA cell therapies to deliver three or more rationally selected and spatially targeted combination therapeutics for a diverse array of diseases."

About the Phase 1/2a Clinical Trial

The Phase 1/2a study (NCT05113342) is an open-label, multicenter, dose escalation trial for Descartes 25 in patients with relapsed and/or refractory multiple myeloma. The study aims to enroll twenty patients who have previously failed two or more lines of treatment to determine the safety and preliminary efficacy of Descartes-25. For more information visit View Source

About RNA Armory

The RNA Armory is Cartesian’s proprietary cell engineering platform that generates large-scale, potent RNA cell therapies with extended protein expression. The RNA Armory is currently focused on RNA engineering two types of cells, T-cells and Mesenchymal Stem Cells (MSCs). Our CAR T-cell programs harness the safety of RNA and autologous engineering to target autoimmune diseases and frontline cancer – without lymphodepletion. Our off-the-shelf MSC programs leverage these cells’ clinical safety record and excellent capacity for protein secretion to deliver synergistic combinations of therapies. For more information visit View Source

On January 25, 2022 Lineberger Comprehensive Cancer Center reported An anonymous donor has made a $25 million gift to establish the UNC Lineberger Center for Triple Negative Breast Cancer and to support other key UNC Lineberger initiatives (Press release, Lineberger Comprehensive Cancer Center, JAN 25, 2022, View Source [SID1234606783]). This is the largest donation in UNC Lineberger’s history, and it enables the cancer center to advance its groundbreaking research on diagnosing and treating a highly aggressive breast cancer that disproportionately affects Black, Latina and young women and historically has limited research funding.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gift was made in gratitude for the care a family member received while being treated for cancer at UNC, and to help expand and expedite the cutting-edge cancer research being conducted at UNC Lineberger. Specifically, the donor designated their investment to help women and men with all types of breast cancer, especially triple negative breast cancer because of its poor prognosis. In addition, the gift will support research directed toward developing more effective treatments for metastatic disease, improving pediatric cancer care, and eliminating racial disparities in cancer treatment outcomes.

Lisa A. Carey, MD, MSc, FASCO, will serve as the inaugural director of the UNC Triple Negative Breast Cancer Center. Carey, the Richardson and Marilyn Jacobs Preyer Distinguished Professor in Breast Cancer Research and a medical oncologist who specializes in treating breast cancer patients, said it is hard to overestimate the gift’s potential impact on advancing triple negative breast cancer research and care.

"While research advances the past 30 years have led to new and more effective treatments for many types of breast cancer, this isn’t the case with triple negative breast cancer," said Carey, who, in addition to her clinical responsibilities, is the deputy director of clinical sciences and co-leader of the breast cancer research program at UNC Lineberger. "The good news is this gift will be a game changer. It provides the cancer center with the resources to expand and speed the pace of our research focused on generating insights that lead to better treatments and outcomes for women with triple negative breast cancer."

Accounting for roughly 10-20% of breast cancer cases in the United States, triple negative breast cancer is so named because it lacks the estrogen, progesterone and HER2 protein receptors commonly associated with other breast cancers. It is an aggressive, fast-growing cancer that has a high risk of spreading beyond the breast and of recurring despite treatment. It has significantly poorer outcomes than other breast cancers, and it disproportionally affects Black, Latina and young women. The only current standard of care involves chemotherapy.

In addition to establishing this new research center, the money will create multiple professorships and accelerate three strategic research initiatives that build on existing UNC Lineberger strengths:

Developing new treatments particularly those that harness a patient’s immune system, including chimeric antigen receptor t-cell (CAR-T) immunotherapy. The objective is more personalized, more effective and less toxic treatment than currently available;
Expanding the genetic understanding and classification of cancer types to improve diagnostics and uncover new targets and modes of therapy;
And creating greater knowledge of nutrition and metabolism and their impact on disease prevention and more holistic treatment options.
"Our world-class researchers at the UNC Lineberger Comprehensive Cancer Center are applying innovative approaches to solving some of the grand challenges of our time," said UNC-Chapel Hill Chancellor Kevin M. Guskiewicz. "Our experts have done foundational work, especially in the space of triple negative breast cancer. Under Lisa Carey’s leadership, they are uniquely positioned to make the most of this generous gift and find life-saving treatments that improve health outcomes for patients in North Carolina and beyond."

Foundational research at UNC Lineberger

UNC Lineberger is internationally recognized for its foundational discoveries that have advanced the field of triple negative breast cancer research.

In 2000, Charles Perou, PhD, the May Goldman Shaw Distinguished Professor of Molecular Oncology and co-leader of the UNC Lineberger breast cancer research program, published a groundbreaking paper identifying the molecular subtypes of breast cancer and demonstrating that breast cancer was not one disease but a collection of diseases with different prognoses. Specifically, the findings defined and characterized the dominant biology underlying triple negative breast cancer.

In 2001, Carey and her UNC Lineberger colleagues launched the first clinical trial in the U.S. that targeted triple negative breast cancers. Through its longstanding population-based study, the Carolina Breast Cancer Study, UNC Lineberger researchers also were the first to demonstrate that triple negative breast cancer disproportionately affected Black women, particularly young black women.

"UNC Lineberger has a world-leading record of advancing understanding of triple negative breast cancer and its therapy," said H. Shelton Earp, MD, UNC Lineberger director. "This remarkable gift will enable us to create an unmatched national hub of research excellence combining and enhancing our expertise in genomics, immunotherapy, and cancer nutrition towards more effective and less toxic therapy for advanced triple negative breast cancer, and with the knowledge gained and our world class community engagement team, better prevention, early detection, and timely therapy for all North Carolina’s rural and urban populations."

"This magnanimous gift is both inspiring and transformative, and it will be life-saving," said A. Wesley Burks, MD, dean of the UNC School of Medicine, vice chancellor for medical affairs, and CEO of UNC Health. "In addition to building on the depth of our expertise in cancer research and care, this gift enables us to focus on uncovering what makes some cancers so difficult to treat and identifying the drivers of racial disparities in cancer treatment outcomes. This is critically important work."

On January 25, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma ("cSCC") (Press release, Checkpoint Therapeutics, JAN 25, 2022, View Source [SID1234606768]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate ("ORR") of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 ("RECIST 1.1") criteria. The median duration of response ("DOR") had not yet been reached at the data cut-off point (76% of responses are ongoing). Safety data across 201 patients with advanced cancers enrolled and treated in all cohorts of the ongoing study remain consistent with those previously reported, with the majority of treatment-emergent adverse events reported as Grade 1 or 2 in severity. Based on these results, Checkpoint intends to submit a Biologics License Application ("BLA") to the U.S. Food and Drug Administration for cosibelimab later this year, to be followed by a marketing authorization application ("MAA") submission in Europe and additional potential submissions in markets worldwide.

"Most people don’t realize that cutaneous squamous cell carcinoma is the second most common form of skin cancer. While treatable with surgery when caught early, cSCC patients diagnosed with advanced disease that has recurred or metastasized have traditionally faced a poor prognosis and often suffer from painful physical discomfort," commented Professor Philip Clingan, Medical Oncologist at Southern Medical Day Care Centre in Australia and co-principal investigator of the trial. "These impressive results demonstrate that cosibelimab, a novel PD-L1 antibody with a unique two-fold mechanism of action, has the potential to offer physicians a new treatment option that provides compelling efficacy, complemented by a favorable tolerability profile, for patients living with this devastating disease."

James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "We are thrilled to report these topline results from our pivotal trial of cosibelimab in metastatic cutaneous squamous cell carcinoma. We believe the strong ORR result is attributable to cosibelimab’s differentiated, two-fold mechanism of action of engaging both T-cells and natural killer cells, while also demonstrating a potential favorable safety profile through its binding to PD-L1, reported in literature as associated with lower rates of severe or worse adverse events as compared to PD-1 therapy. We extend our sincere thanks to the patients, caregivers, investigators and their site staff for their dedication to this trial, particularly during these challenging times globally. We look forward to a detailed presentation of the data at an upcoming medical meeting."

Mr. Oliviero continued, "Upon approval, we intend to position cosibelimab at a lower price point than currently available PD-(L)1 therapies, which we hope will lead to meaningful market share in the U.S. and international markets around the world. We also believe the safety and efficacy profile of cosibelimab could make cosibelimab an attractive agent for use in combination regimens, potentially with drug candidates within our current portfolio, additional molecules we may in-license, and synergistic molecules through potential collaborations, particularly those that can take advantage of the two-fold mechanism of action of cosibelimab."

Additionally, Checkpoint continues to enroll a registration-enabling cohort of patients with locally advanced cSCC, anticipating this potential second indication could be included in the planned initial BLA submission, as well as the global, randomized Phase 3 (CONTERNO) trial of cosibelimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer.

Conference Call Information

Checkpoint will host a conference call today, Tuesday, January 25, 2022, at 8:30 AM ET to discuss the topline results. In order to participate in the conference call, please dial 1-877-269-7756 (U.S.), 1-201-689-7817 (outside of the U.S.).

A live webcast of this conference call will be available on the IR Calendar page under News & Events, located within the Investors section of Checkpoint’s website, View Source, and an audio recording of the conference call will also be available for replay for a period of approximately 30 days following the call.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced and an estimated 15,000 people will die from their disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab

Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On January 25, 2022 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported an update to the Proprietary Laboratory Analyses (PLA) code for its comprehensive genomic profiling test, PGDx elio tissue complete (Press release, Personal Genome Diagnostics, JAN 25, 2022, View Source [SID1234606784]). The Centers for Medicare & Medicaid Services (CMS) finalized a national reimbursement rate of $2,919.60 for the PLA code (0250U) that PGDx obtained for the test.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled that CMS has responded to PGDx’s advocacy efforts, agreeing with our crosswalk recommendation for the previously obtained PLA code," said PGDx CEO Megan Bailey. "The PGDx elio tissue complete test enables rapid and actionable genomic insights for patients living with advanced cancers, and the national reimbursement rate as determined by CMS will allow for more patients to receive targeted insights and informed treatment options that could improve outcomes."

The new Medicare payment rate went into effect on January 1, 2022. More information can be found in the latest Medicare Clinical Laboratory Fee Schedule Files.

The PGDx elio tissue complete solution is an in-house comprehensive genomic profiling (CGP) test that identifies key genomic alterations and guideline supported biomarkers in solid tumors using a 500+ gene panel. PGDx elio tissue complete is the industry’s first and only NGS diagnostic kit for comprehensive tumor profiling that is FDA cleared and CE-IVD marked for use in labs worldwide.